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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
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nmi port, nmi port ii NAVILYST MEDICAL, INC. k153228 12/04/2015
bladder scanner Caresono Technology Co., Ltd. k153581 04/08/2016
full automatic (nibp) blood pressure monitor Health & Life Co., Ltd. k160336 03/29/2016
certa dose pd epinephrine 1mg/ml im/sc syringe CERTA DOSE, INC. k160589 01/19/2017
powder free vinyl patient examination glove, colored (yellow) KAIXING PLASTIC PRODUCTS CO., LITD. k160675 08/02/2016
esophyx® z device with serosafuse fasteners and accessories ENDOGASTRIC SOLUTIONS, INC. k160960 05/01/2016
s-clean oneq-sl narrow implant system Dentis Co., Ltd. k161244 12/07/2016
scopis hybrid navigation system em Scopis GmbH k161491 02/09/2017
single use curved cutters, single use circular staplers, single use linear cutters and reloads, single use endoscopic linear cutters and reloads, single use hemorrhoidal staplers, single use linear staplers and reloads VICTOR MEDICAL INSTRUMENTS CO.,LTD. k161757 12/05/2016
magnetos XPAND BIOTECHNOLOGY BV k161859 02/24/2017

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